Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
stomach feels wonky; Patient was not feeling great at all; Patient woke up in the middle of the night with arm hurts at the site of the injection; Patient had chills; Patient feel a bit nauseous/dry-heaving; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach feels wonky), MALAISE (Patient was not feeling great at all), VACCINATION SITE PAIN (Patient woke up in the middle of the night with arm hurts at the site of the injection), CHILLS (Patient had chills) and NAUSEA (Patient feel a bit nauseous/dry-heaving) in a 72-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient had four vaccines from Moderna in the past with no adverse reaction.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included AFib (diagnosed with A-fib 2 years ago). On 08-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 09-Sep-2025, the patient experienced ABDOMINAL DISCOMFORT (stomach feels wonky), MALAISE (Patient was not feeling great at all), VACCINATION SITE PAIN (Patient woke up in the middle of the night with arm hurts at the site of the injection), CHILLS (Patient had chills) and NAUSEA (Patient feel a bit nauseous/dry-heaving). At the time of the report, ABDOMINAL DISCOMFORT (stomach feels wonky), MALAISE (Patient was not feeling great at all), VACCINATION SITE PAIN (Patient woke up in the middle of the night with arm hurts at the site of the injection), CHILLS (Patient had chills) and NAUSEA (Patient feel a bit nauseous/dry-heaving) had not resolved. No concomitant medications were provided. Patient did not know which vaccine and report was received, no paperwork with a product name nor lot number. Patient got a Moderna COVID shot late yesterday afternoon. It seemed to be okay after that shot, but the patient woke up in the middle of the night with arm hurts at the site of the injection. And now this morning, the patient was not feeling great at all. The patient had chills and felt a bit nauseous. The patient had not vomited or anything yet. The patient had dry-heaving and even though stomach felt wonky, it was like nothing came up. The patient never had symptoms like that before after a Covid shot. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. Reporter did not allow further contact
AFib (diagnosed with A-fib 2 years ago)